Summary
Authors and revises GMP documents.
Authoring new documents to support raw material testing including, but not limited to, specification authoring and Certificate of Analysis creation.
Revising existing documents as needed.
Managing the development of documents through the electronic document management system.
Assisting in the execution of Change Controls as needed.
Working with internal teams to obtain an in-depth understanding of QC processes and their documentation requirements.
Producing high-quality documents that meet applicable standards and are appropriate for their intended audience.
Writing easy to understand instructions where required.
Creating tutorials to help end-users train on a variety of activities.
Creating and maintaining documentation projects and timelines.
Providing excellence attention to detail when writing or revising documents.
Applying critical thinking skills when developing documents for new procedures.
Performs other tasks as assigned.
Role Requirements:
Bachelors degree required, preferably in chemistry, microbiology, or related science; Advanced degree preferred.
An equivalent combination of education and experience will be considered.
4 years of relevant work experience, preferably in a regulated environment.
Proven work experience in authoring and revising GMP documents.
Ability to deliver high-quality documentation while paying attention to detail.
Ability to quickly grasp complex technical concepts and make them easily understandable through text and pictures.
Excellent English writing skills.
Strong working knowledge of Microsoft Office.
Familiarity with GMP electronic documentation systems.
Ability to work in a highly regulated environment and to follow Good Documentation Practices (GDPs).
Advanced ability to work in a collaborative team environment and train others.
Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.
Ability to set priorities for the group and mentor associates.
Strong organizational skills and critical thinking skills.
Advanced Excel and/or Smartsheets is a plus!